NHRA MDR Transition Guideline: Overview
The article describes in detail the transitional arrangements associated with the recent regulatory changes in the European Union.
The article describes in detail the transitional arrangements associated with the recent regulatory changes in the European Union.
The article provides a general overview of a vigilance system applicable to CE-marked medical devices intended to be marketed and used in the EU and also highlights certain specific aspects associated thereto.
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices. Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...